Investigating the Pharmacokinetics of Subcutaneous Injections With [amount hidden], and [amount hidden] Semaglutide Strengths and the Absolute Bioavailability of Semaglutide

What Was Tested

This registered phase 1 trial tested Semaglutide.

This trial is conducted in Europe.

It had eight arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

42 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy male or female subjects (based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the investigator). Age between 18 and 55 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 20 and 30 kg/m\^2 (both inclusive).

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: history of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test; smoking or use of any nicotine products (including nicotine patches, gum etc.) in the last 3 months prior to screening or a positive nicotine test.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Semaglutide and the comparison in turn, acting as their own control.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2014-09 with completion listed for 2015-01.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the semaglutide plasma concentration curve (time frame: From day 0-day 35/840 hours).

It also tracked 3 secondary outcomes, for example Maximum observed semaglutide plasma concentration, Area under the semaglutide plasma concentration-time curve and Number of treatment emergent adverse events (TEAEs).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 42 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.